Featured Articles

1. Parenteral Drug Manufacturing — Innovation Begins With A Problem 6/11/2020

   Developing manufacturing processes for complex parenteral drug formulations often presents some of the most challenging problems—and innovative solutions —pharmaceutical scientists and engineers face.

2. Meet A Project Ambassador - Michelle Ava

   Michelle has dedicated her career to simplifying organizational processes, making jobs easier and more efficient. Using a system of her own design, she mines data for relevant material to turn into reliable, actionable information to support executive team decision-making.

3. Five Trends Driving Lyophilization 9/20/2022

   Learn more about the trends driving the need for lyophilization: biopharmaceuticals, scalability, a growing geriatric population, rising chronic diseases, and cold chain and storage.

4. Innovative Therapies Supporting 503B Of The Federal Food, Drug, And Cosmetic Act (FD&C Act) 11/24/2020

   Innovative therapies including customized, patient-specific compounds, are transforming healthcare, and presenting new challenges for pharmaceutical development, manufacturing, and supply chain management. Our healthcare ecosystem is experiencing tectonic shifts and providing a reliable supply of safe and effective medicines for hospitals and clinics to use for their patients will require an innovative, problem-solving mindset.

5. How A CDMO Achieves Finished Product Lyophilization With Limited And Expensive API 6/27/2022

   Agile, cost-effective lyophilization services can accelerate the development of complex drug candidates that present stability challenges, but lyophilization can be challenging, expensive, and time-consuming.

6. Complex Parenteral Drug Manufacturing — A Foundation For Success 6/11/2020

   A first-hand account of what it takes to develop and manufacture complex parenteral drugs.

7. Demystifying Highly Potent API And Cytotoxic Drug Products

   The concept of development, process design, and manufacturing of drugs with a HPAPI or cytotoxic compounds should not be a mystery to drug sponsors using a CDMO. Gathering, organizing, and understanding critical risk data related to HPAPIs and cytotoxic drugs ensures appropriate controls are defined from concept to clinical batch manufacturing to commercial-scale manufacturing.

8. The Value Of Orphan Drug Designation

   More than 90% of rare diseases still have no FDA-approved treatment, even though rare diseases affect more than 25 million Americans. Despite the opportunities in the orphan drug market, there are challenges that may act as barriers to entry.

9. Creating A New Dosage Form From An Approved Drug For A New Rare Disease Indication 7/22/2020

   Cure HHT, a foundation representing patients suffering from Hereditary Hemorrhagic Telangiectasia, a genetic blood vessel disorder that causes bleeding in multiple organs, needed assistance in developing a formulation and filing an Investigational New Drug (IND) application with the FDA.

10. Drug Repurposing Advantages And Strategies

    Identifying new therapeutic uses for old, existing, or available drugs is an effective strategy in discovering or developing drug molecules with new pharmacological and therapeutic indications.